LegalizeCommission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005 (Text with EEA relevance)
COMMISSION DELEGATED REGULATION (EU) 2015/1011
of 24 April 2015
supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005
(Text with EEA relevance)
Article 1
Subject matter
This Regulation lays down conditions for granting licences and registrations, determines cases where a licence and a registration are not required, establishes the criteria to demonstrate the licit purpose of a transaction, determines the information required to monitor trade, fixes the conditions for determining the lists of the countries of destination for exports of scheduled substances of Categories 2 and 3, establishes the criteria for determining simplified procedures for pre-export notifications and for export authorisations and specifies the requirements concerning the information to be provided on the implementation of the monitoring measures as regards trade in drug precursors.
Article 2
Definitions
For the purposes of this Regulation, ‘business premises’ shall mean building(s) together with the land occupied by an operator at each single location.
Article 3
Conditions for granting licences
In order to obtain a licence pursuant to Article 6(1) of Regulation (EC) No 111/2005, the operator shall appoint an officer responsible for the trade in scheduled substances listed in Category 1 of the Annex to that Regulation, notify the competent authority of the name and contact details of that officer and notify them immediately of any subsequent modification of this information.
The responsible officer shall ensure that import, export or intermediary activities take place in compliance with the pertinent legal provisions and shall be empowered to represent the operator and to take the decisions necessary for performing that task.
The operator concerned shall fulfil all the following requirements and conditions:
(a)the operator shall take adequate measures against the unauthorised removal of scheduled substances of Category 1 of Annex I to Regulation (EC) No 273/2004 and of the Annex to Regulation (EC) No 111/2005 from the places of storage, production, manufacture and processing of scheduled substances and to secure business premises;
(b)the operator shall make an application containing the following:
(i)the full name, address, telephone and/or fax numbers and email address of the applicant;
(ii)the full name of the responsible officer and his/her contact details;
(iii)a description of the position and tasks of the responsible officer;
(iv)the full addresses of the business premises;
(v) the description of all the places where operations described under point (ix) take place;
(vi)information showing that the adequate measures referred to in paragraph 2(a) have been taken;
(vii)the name and the CN code of the scheduled substances as stated in Annex I to Regulation (EC) No 273/2004 and in the Annex to Regulation (EC) No 111/2005;
(viii)in the case of a mixture or natural product an indication of the following:
(a)the name of the mixture or natural product;
(b)the name and CN code of the scheduled substances as stated in Annex I to Regulation (EC) No 273/2004 and in the Annex to Regulation (EC) No 111/2005 contained in the mixture or natural product;
(c)the maximum percentage of such scheduled substances in the mixture or natural product;
(ix)a description of the envisaged type of operations referred to in Article 3 of Regulation (EC) No 273/2004 and in Article 6(1) of Regulation (EC) No 111/2005;
(x)an authenticated copy of the Register of companies or activities, where relevant;
(xi)a certificate of good conduct of the operator concerned and of the responsible officer or a document showing that they offer the necessary guarantee for the proper conduct of the operations or the information allowing the competent authority to obtain such document.
If the operator has already been granted the status of an Authorised Economic Operator in accordance with Article 5a of Council Regulation (EEC) No 2913/92 (1); he may indicate the AEO certificate number when making the application for a licence for the purpose of the competent authority being able to take his AEO status into consideration.
Upon written request from the relevant competent authority, the applicant shall submit any relevant additional information.
Where the applicant is a natural person, points (ii) and (iii) of paragraphs 2(b) shall not apply, and point (iv) of paragraph 2(b) shall only apply where relevant.
Without prejudice to measures adopted in accordance with Article 10(1) of Regulation (EC) No 273/2004 and with Article 26(3) of Regulation (EC) No 111/2005, the competent authority shall refuse the granting of the licence if the conditions set out in Article 3(2)(b) of this Regulation are not fulfilled or if there are reasonable grounds for suspecting that the scheduled substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances.
In the case of trade between the Union and third countries referred to in Regulation (EC) No 111/2005, the competent authority may either limit the validity of the licence to a period not exceeding three years or may require operators to demonstrate at intervals not exceeding three years that the conditions under which the licence was granted are still fulfilled.
The validity of licences issued before the entry into force of this Regulation shall not be affected.
A licence shall not be transferable.
The licence holder shall apply for a new licence where any of the following are envisaged:
(a)the addition of a scheduled substance;
(b)the start of a new operation;
(c)the change of the location of the business premises where the operations take place.
In such cases, the existing licence shall cease to be valid on the earlier of the following dates:
(i) the date of expiry of validity where a term of validity has been fixed in accordance with Article 3(7) of this Regulation or in accordance with Article 3(5) of Regulation (EC) No 273/2004;
(ii)the date of commencement of validity of the new licence.
Paragraph 9 shall also apply to licences issued before the date of application of this Regulation.
Paragraphs 2 to 6 and 8, 9 and 10 shall also apply for the purpose of obtaining licences pursuant to Article 3(2) of Regulation (EC) No 273/2004, with the exception of special licences.
The public authorities referred to in Article 3(2) and (6) of Regulation (EC) No 273/2004 shall comprise customs, police and official laboratories of competent authorities.
Article 4
Cases where a licence is not required
Pharmacies, dispensaries of veterinary medicine, customs, police, armed forces and official laboratories of competent authorities may be exempted from the requirement of licensing pursuant to Article 6(1) of Regulation (EC) No 111/2005 in so far as these operators use drug precursors within the scope of their official duties.
The operators set out in the first paragraph are also exempted from the following:
(a)the provision of documentation referred to in Article 3 of Regulation (EC) No 111/2005;
(b)the obligation to appoint a responsible officer set out in Article 3(1) of this Regulation.
Article 5
Conditions for granting registrations
In order to obtain a registration pursuant to Article 7(1) of Regulation (EC) No 111/2005, the operator shall appoint an officer responsible for the trade in scheduled substances listed in Category 2 of the Annex to that Regulation, notify the competent authority of the name and contact details of that officer and notify them immediately of any subsequent modification of this information.
The responsible officer shall ensure that import, export or intermediary activities take place in compliance with the pertinent legal provisions and shall be empowered to represent the operator and to take the decisions necessary for performing that task.
The operator of scheduled substances of Category 2 of the Annex to Regulation (EC) No 111/2005 shall make an application containing the information and documents as referred to in Article 3(2)(b) with the exception of points (vi), (x) and (xi).of Article 3(2)(b), unless so requested by the competent authority.
The same applies to the operator engaged in the export of scheduled substances of Category 3 of the Annex to Regulation (EC) No 111/2005.
Article 3(3) and (4) shall also apply.
The first subparagraph of paragraph 2 and paragraph 3 shall apply mutatis mutandis to operators and users referred to in Article 3(6) of Regulation (EC) No 273/2004 in respect of scheduled substances of Category 2 of Annex I to that Regulation.
Users of scheduled substances of category 2A of Annex I to Regulation (EC) No 273/2004 shall also provide information on the use of the scheduled substances.
Article 6
Cases where a registration is not required
The following categories may be exempt from the registration requirement pursuant to Article 7(1) of Regulation (EC) No 111/2005:
(a)pharmacies, dispensaries of veterinary medicine, customs, police, official laboratories of competent authorities and armed forces, insofar as these operators use drug precursors within the scope of their official duties;
(b)operators engaged in the export of scheduled substances listed in Category 3 of the Annex to Regulation (EC) No 111/2005, if the sum of quantities concerned by their exports during the course of the preceding calendar year (1 January-31 December) does not exceed the amounts specified in Annex I to this Regulation. When those amounts are exceeded within the current calendar year, the operator shall comply with the registration requirement immediately;
(c)operators engaged in export of mixtures containing scheduled substances listed in Category 3 of the Annex to Regulation (EC) No 111/2005, if the amount of the scheduled substance contained in the mixtures does not exceed, during the course of the preceding calendar year, the amounts specified in Annex I to this Regulation. When those amounts are exceeded within the current calendar year, the operator shall comply with the registration requirement immediately.
Article 7
Conditions for exemptions from certain requirements
For the purposes of Article 6 of Regulation (EC) No 273/2004, customers shall inform their suppliers whether that Article is applicable to them.
Article 8
Criteria for determining the licit purposes of a transaction
The operator shall provide information that the consignment has left the country of export in accordance with the national provisions in force adopted pursuant to Article 12 of the Convention of the United Nations against illicit traffic in Narcotic Drugs and Psychotropic substances (2) to demonstrate the licit purpose of his transaction pursuant to Article 8(1) of Regulation (EC) No 111/2005.
For that purpose, the operator shall either use the model set out in Annex II to this Regulation or present the import authorisation referred to in Article 20 of Regulation (EC) No 111/2005 or the customer declaration referred to in Article 4 of Regulation (EC) No 273/2004.
Article 9
Information required to monitor trade
For the purposes of Article 8(2) of Regulation (EC) No 273/2004 operators shall inform the competent authorities in a summary form of the quantities of scheduled substances used or supplied and, in the case of supply, of the quantity supplied to each third party.
For scheduled substances of Category 3 of Annex I to Regulation (EC) No 273/2004, the first paragraph shall apply only upon request by the competent authorities.
For the purposes of Article 9(2) of Regulation (EC) No 111/2005, operators shall inform the competent authorities about the following:
(a)exports of scheduled substances subject to an export authorisation;
(b)all imports of scheduled substances of Category 1 of the Annex to Regulation (EC) No 111/2005 requiring an import authorisation or all cases where scheduled substances of Category 2 of the Annex to Regulation (EC) No 111/2005 are entered into a free zone of control type II, placed into a suspensive procedure other than transit, or released for free circulation;
(c)all intermediary activities involving scheduled substances of Categories 1 and 2 of the Annex to Regulation (EC) No 111/2005.
The information referred to in paragraph 2(a) shall be organised by making reference to the countries of destination, quantities exported and the reference numbers of the export authorisations as the case may be.
The information referred to in paragraph 2(b) shall be organised by making reference to the third country of export and the reference number of the import authorisations as the case may be.
The information referred to in paragraph 2(c) shall be organised by making reference to the third countries involved in these intermediary activities and the export or import authorisation as the case may be. Operators shall provide further information, upon request of the competent authorities.
The competent authorities shall treat the information referred to in this Article as confidential business information.
Article 10
Conditions for determining the lists of the countries of destination for exports of scheduled substances of Categories 2 and 3
The lists referred to in Article 11(1) of Regulation (EC) No 111/2005 shall include all of the following:
(a)third countries with whom the Union has concluded a specific agreement on drug precursors;
(b)third countries which have requested to receive pre-export notifications in accordance with Article 12(10) of the 1988 United Nations Convention against illicit traffic in narcotic drugs and psychotropic substances;
(c)third countries which have requested to receive pre-export notifications in accordance with Article 24 of the 1988 United Nations Convention against illicit traffic in narcotic drugs and psychotropic substances.
The lists of the specific countries of destination for export of scheduled substances listed in Categories 2 and 3 of the Annex referred to in points (a), (b) and (c) shall be published on the website of the Commission.
Article 11
Criteria for determining simplified procedures for pre-export notifications
Pursuant to Article 11(3) of Regulation (EC) No 111/2005, the competent authority may send a simplified pre-export notification covering several export operations carried out within a specific time period of either 6 or 12 months, in case of exports intended for the simplified export authorisation procedure.
The competent authority of the country of export shall supply the information specified in Article 13(1) of Regulation (EC) No 111/2005 to the competent authority of the third country of destination.
The competent authority shall inform the country of destination accordingly and use to that purpose the PEN-online system or the ‘Multilateral Chemical Reporting Notification’ set out in Annex III of this Regulation.
Article 12
Criteria for determining simplified procedures for export authorisations
Following an application by the operator concerned the competent authority may grant an export authorisation by simplified procedure pursuant to Article 19 of Regulation (EC) No 111/2005 in cases of frequent exports of one specific scheduled substance listed in Categories 3 and 4 of the Annex to that Regulation involving the same exporter established in the Union and the same importer in the same third country of destination covering a specific time period of either 6 or 12 months.
Such simplified export authorisation may only be granted in the following cases:
(a)where during previous exports the operator has shown the capacity to fulfil all obligations in relation to those exports, and has not committed any offences against relevant legislation;
(b)where the competent authority can satisfy itself as to the licit purposes of those export operations.
The application for a simplified export authorisation shall contain at least the following:
(a)the names and addresses of the exporter, the importer in the third country, and the ultimate consignee;
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